- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02363166
Analysis of CA-MRSA Transmission: An ED Population Sampling Strategy
Molecular Epidemiology and Phylodynamic and Phylogeographic Analysis of Community-associated Methicillin-resistant Staphylococcus Aureus (CA-MRSA) Transmission: An Emergency Department Population Sampling Strategy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Prospective cross-sectional study involving 500 patients enrolled over a one year period at the UFHealth Shands Hospital's Adult and Pediatric Emergency Department. The collected information will serve as pilot data for a future large comprehensive multi-site study.
Patients will have a wound culture and a nasal swab obtained as part of the study, which will be assessed for MRSA isolates using next-generation whole genome sequencing. The principal investigator or PI designee will also survey participants and review hospital records.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
Florida
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Gainesville, Florida, United States, 32608
- UF Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient or Legally Authorized Representative (LAR) must have voluntarily signed an Institutional Review Board-approved informed consent form before initiation of any study procedures
- Patient presents with an acute abscess or a non-post-operative skin/soft tissue infection
- Patient presents through the UFHealth Shands Emergency Department
Exclusion Criteria:
- Patients who are employed by UFHealth and provide direct patient care
- Patients who have previously been enrolled in the study
- Patients who are not suitable for the study in the opinion of the investigator
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Acute Abscess Group
Adults and pediatric patients presenting to the UFHealth Shands Emergency Department with evidence of an acute abscess, or skin/soft tissue infection, which can be sampled for culture and sensitivity testing will be recruited.
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Samples collected for culture and sensitivity testing depending on acute abscess, or skin/soft tissue infection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strain Relatedness Identification Through Phylogenetic Analysis
Time Frame: 1 Hour
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Molecular (spa-typing) and genomic (WGS) relatedness of MRSA strains in isolates in ED populations presenting with SSTIs.
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1 Hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strain Transmission Through Analysis of Genetic Clustering
Time Frame: 1 year
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Phlyodynamic analysis of MRSA transmission course by strain
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1 year
|
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Patient Level Characteristics of Skin and Soft Tissue Infection (SSTI) Presentation
Time Frame: 6 Months
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To determine patient-level characteristics, including social and medical history, associated with a presentation related to SSTIs.
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6 Months
|
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Pediatric and Adult Population Presentation Characteristics in Skin and Soft Tissue Infection (SSTI)
Time Frame: 6 Months
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Compare patient-level characteristics and phylogenetic clustering between pediatric and adult patients presenting with SSTIs.
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6 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph A Tyndall, MD, University of Florida
Publications and helpful links
General Publications
- Burton DC, Edwards JR, Horan TC, Jernigan JA, Fridkin SK. Methicillin-resistant Staphylococcus aureus central line-associated bloodstream infections in US intensive care units, 1997-2007. JAMA. 2009 Feb 18;301(7):727-36. doi: 10.1001/jama.2009.153.
- Climo MW. Decreasing MRSA infections: an end met by unclear means. JAMA. 2009 Feb 18;301(7):772-3. doi: 10.1001/jama.2009.149. No abstract available.
- Prosperi M, Veras N, Azarian T, Rathore M, Nolan D, Rand K, Cook RL, Johnson J, Morris JG Jr, Salemi M. Molecular epidemiology of community-associated methicillin-resistant Staphylococcus aureus in the genomic era: a cross-sectional study. Sci Rep. 2013;3:1902. doi: 10.1038/srep01902.
- Park SH, Park C, Yoo JH, Choi SM, Choi JH, Shin HH, Lee DG, Lee S, Kim J, Choi SE, Kwon YM, Shin WS. Emergence of community-associated methicillin-resistant Staphylococcus aureus strains as a cause of healthcare-associated bloodstream infections in Korea. Infect Control Hosp Epidemiol. 2009 Feb;30(2):146-55. doi: 10.1086/593953.
- Wu D, Wang Q, Yang Y, Geng W, Wang Q, Yu S, Yao K, Yuan L, Shen X. Epidemiology and molecular characteristics of community-associated methicillin-resistant and methicillin-susceptible Staphylococcus aureus from skin/soft tissue infections in a children's hospital in Beijing, China. Diagn Microbiol Infect Dis. 2010 May;67(1):1-8. doi: 10.1016/j.diagmicrobio.2009.12.006. Epub 2010 Mar 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201400426
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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